Regulate gene-editing — now: This technology strikes at the core of what it means to be human

By Francis Fukuyama

|NEW YORK DAILY NEWS|

Dec 04, 2015 | 5:00 AM

Don’t buy the hype (AgfaScns)

The news that Chinese researchers recently attempted to alter what is called the "germline" of human embryos — essentially, rewriting sentences in our genes — has set off a huge and necessary discussion of how we should deal with genetic engineering. In Washington this week, a large international conference, featuring big-name scientists from around the world, sought to grapple with the moral and ethical consequences of these developments.

The Chinese experiment was made possible by the development of a new technology known as CRISPR, which for the first time provides a fast and easy way of editing individual genes in a chromosome. The moment when we will be able to alter characteristics that will be handed down to all future generations of human beings is upon us.

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These developments have re-ignited a huge debate over the proper uses of this technology. The ability to permanently alter human characteristics, from predisposition to disease to looks to intelligence to aggression, raises both huge opportunities and dangers.

In my view, this type of activity potentially strikes at the core of what it means to be human. It is not something that should simply be left up to market forces, or to the whims of curious researchers; rather, we need as a society to establish some red lines regarding uses of this technology.

One that I would personally draw is between therapeutic and enhancement uses of gene editing: While the boundary can sometimes be fuzzy, it is far more legitimate to help people subject to inherited genetic diseases than to spend money so that a rich family can enhance the appearance and acumen of their children.

But no ethical red line will be meaningful unless it can be enforced, which means that we as a society need to regulate the practice of assisted reproductive medicine, which is where such experiments would likely be carried out. No such regulation exists today in the United States, apart from self-regulation by the assisted reproduction industry.

It may surprise people to know that it is today perfectly legal for a scientist or doctor to try to clone a human being, or to repeat the Chinese experiments. The Food and Drug Administration has in the past tried to exert some authority in this area on the dubious grounds that embryos are "medical products" — a rather strange claim. In any event, the FDA has no capacity to make moral distinctions between ethical and unethical uses of genetic engineering.

When the prospect of such engineering first appeared in the 1970s, a coalition of scientists and business interests worked to beat back formal regulation, in favor of things like toothless bioethics advisory boards.

What we need today instead is a new statutory authority with oversight power over germline engineering and similar reproductive technologies to make it clear what is and is not permissible. Other advanced countries have long since put similar institutions in place, like Britain's Human Fertilisation and Embryology Authority.

In the past, such regulation has been made impossible in the U.S. due to an unlikely coalition of scientists and biotech firms on the one hand, who want no limits on research, and pro-life groups on the other. The latter worry that any law outlawing some forms of embryo research but not others will legitimate abortion.

But the technology is moving ahead too rapidly for us to be hung up by such concerns. We need to worry not just about embryos, but about the children that will be produced by an unregulated technology.

We need to address the regulatory problem on an international level as well. As the Chinese case suggests, the first experiments in germline engineering will take place in Asia. Asian value systems tend not to as sharp a distinction between human and non-human as Christianity does, and therefore has always been more relaxed about abortion and embryo experimentation.

We do not want to find ourselves in an arms race with China for which country will produce the most perfect engineered human babies first. The very idea is morally repugnant, but in the cards as things stand now.

The recent conference in Washington spent a lot of time rehashing familiar arguments about the pros and cons of genetic engineering, and not nearly enough time thinking through what a concrete regulatory framework for new reproductive technologies would look like. The time for doing so is quickly passing as the technology advances.

Fukuyama is a senior fellow at Stanford and director of its Center on Democracy, Development and the Rule of Law and the author of "Our Posthuman Future: Consequences of the Biotechnology Revolution."